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一项针对生殖器疱疹感染高危人群的2型单纯疱疹病毒糖蛋白疫苗的双盲、安慰剂对照试验。

Double-blind, placebo-controlled trial of a herpes simplex virus type 2 glycoprotein vaccine in persons at high risk for genital herpes infection.

作者信息

Mertz G J, Ashley R, Burke R L, Benedetti J, Critchlow C, Jones C C, Corey L

机构信息

Department of Laboratory Medicine, University of Washington, Seattle.

出版信息

J Infect Dis. 1990 Apr;161(4):653-60. doi: 10.1093/infdis/161.4.653.

DOI:10.1093/infdis/161.4.653
PMID:2181031
Abstract

To determine the efficacy of a herpes simplex virus type 2 (HSV-2) glycoprotein subunit vaccine, vaccine (50 micrograms) or placebo was administered intramuscularly at weeks 0, 4, and 22 to 161 persons who lacked HSV-2 antibodies and were sex partners of persons with recurrent genital herpes. The annual rate of acquisition of HSV infection was similar among vaccine and placebo recipients (10.7% and 8%, respectively) but was higher in initially seronegative subjects (15.5%) than in those with HSV-1 at entry (5.9%). Eleven (79%) of the 14 HSV infections acquired during follow-up were symptomatic. Vaccination elicited ELISA antibody titers to glycoproteins gD2 and gB2 that were only 10% and 5%, respectively, of titers found in persons with recurrent genital HSV-2 infection. This vaccine failed to provide protection from acquisition of genital HSV infection. The lack of efficacy appears to be related, in part, to the poor immunogenicity of the vaccine.

摘要

为确定2型单纯疱疹病毒(HSV - 2)糖蛋白亚单位疫苗的疗效,对161名缺乏HSV - 2抗体且为复发性生殖器疱疹患者性伴侣的人,于第0、4和22周肌肉注射疫苗(50微克)或安慰剂。疫苗接种者和安慰剂接受者中HSV感染的年发生率相似(分别为10.7%和8%),但初始血清阴性的受试者(15.5%)的发生率高于入组时已有HSV - 1感染的受试者(5.9%)。随访期间获得的14例HSV感染中有11例(79%)出现症状。接种疫苗后引发的针对糖蛋白gD2和gB2的ELISA抗体滴度,分别仅为复发性生殖器HSV - 2感染患者中所测滴度的10%和5%。该疫苗未能预防生殖器HSV感染。疗效欠佳似乎部分与疫苗免疫原性较差有关。

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